How will ICH E8 (R1) and E6 (R3) Make Clinical Trials Oversight More Efficient?

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Drug Safety,
  • Tuesday, August 31, 2021

As the complexity of clinical trials continues to increase, so does the importance of CROs to the pharmaceutical industry. Outsourcing allows pharmaceutical companies to utilize on-demand services, improving operational efficiencies by accessing therapeutic expertise and geographic reach. This reflects a sharper focus on core competencies and a shift to allow CROs to manage and conduct clinical trials.

ICH-based regulations have traditionally led to more overhead in the form of processes, headcounts and systems. These regulations concerning oversight cascade to all stakeholders further increasing complexity and associated costs.

Register for this webinar to hear about the forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines, which renew the focus on efficiencies in conducting clinical trials and provide tools to do so – significantly impacting oversight.


Janis Hall, WCG Avoca

Janis Hall Senior Consultant, WCG Avoca

Janis Hall has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), she was responsible for R&D sourcing, contracting and supplier alliance management. As Senior Consultant with WCG Avoca, Janis developed many of the quality oversight tools within the Avoca Quality Consortium Knowledge Center. She is also the mastermind behind the Oversight Capability and Maturity Model (OCMM) and Provider Qualification work streams. Janis has been a chair, invited speaker, and panelist at numerous conferences. She holds an MBA from the University of Delaware and a BS in Chemistry from Towson University.

Message Presenter
Andy Lawton, Risk Based Approach Ltd

Andy Lawton, Consultant, Risk Based Approach Ltd

Andy is one of the world’s leading experts on the implementation of risk management and Quality by Design in clinical development. He has provided ICH E6 R2 and ICH E8 consulting to over 40 companies/groups across five continents. Andy has extensive experience in computing, statistics, data management, RDE/RDC, system design and Risk Based Approach in both CSV and clinical trials.

Andy has 46 years of experience in the pharmaceutical industry and the U.K.’s NHS, and was a founding committee member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publications include the paper with Dr. Alistair Ross on GP Audit. Throughout the 80’s and 90’s this was the most-quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.

Message Presenter
Elvin Thalund, Oracle Health Sciences

Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences

Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences’s effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in industrial engineering from Aalborg University.

Message Presenter

Who Should Attend?

Sponsor and CRO roles who are responsible for:

  • Vendor oversight
  • Clinical data management: collecting and evaluating trial metrics
  • Project management of studies and operational excellence

What You Will Learn

In this webcast, the speakers will explore:

  • The intended purpose of ICH regulations – to implement industry best practices, and not to add additional burdens on clinical research staff.
  • The tools provided by ICH E6 and E8 guidance’s to drive efficiencies in clinical trials.
  • Strategies for quick, relatively straightforward adoption of the new guidelines and best practice approaches to implement these tools now.
  • How technology can assist in risk management and vendor oversight.
  • How by applying critical thinking to risk management, organizations can improve their operational efficiencies by minimizing duplicate quality-assurance steps.

Xtalks Partner

Oracle Health Sciences

As a leader in Life Sciences cloud technology, Oracle Health Sciences’ Clinical One and Safety One are trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance. With over 20 years’ experience, Oracle Health Sciences is committed to supporting clinical development, delivering innovation to accelerate advancements, and empowering the Life Sciences industry to improve patient outcomes. Oracle Health Sciences. For life.

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